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This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.
Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.
Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.
The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VDD | Active Comparator | A pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria. |
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| DDDR | Experimental | DDDR pacing mode added atrial support to these using an accelerometer-based rate-responsive sensor which should be able to increase heart rate when needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial pacing support | Other | Use a pacing mode with atrial pacing including a rate-resposive sensor. |
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| Measure | Description | Time Frame |
|---|---|---|
| distance walked during the 6MWT | distance walked during the 6-minute-walking-test (6MWT) | A consecutive 6-month treatment period with the same pacing mode. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Centrale di Bolzano | Bolzano | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39701488 | Derived | Donazzan L, Bulian F, Maines M, Erckert M, Peruzza F, Rauhe WG, Giacopelli D, Manfrin M. Effect of rate-adaptive atrial support compared to VDD pacing in cardiac resynchronization therapy recipients: A randomized cross-over study. Am Heart J. 2025 Mar;281:149-156. doi: 10.1016/j.ahj.2024.12.005. Epub 2024 Dec 17. |
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Privacy concerns.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized, cross-over, double-blind, multicenter study
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| Atrial tracking pacing mode | Other | A pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria. |
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